Randomised Controlled Trial PFC Versus CKS Total Knee Prostheses

NCT ID: NCT00228137

Last Updated: 2007-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-11-30

Study Completion Date

2012-11-30

Brief Summary

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The purpose of this study is to compare the functional outcome of two different total knee prostheses in a prospective randomised study.

Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

All patients on the waiting list for a TKA due to an invalidating gonarthrose as a result of osteo-arthrosis or secondary to a rheumatic disease or a trauma.

Exclusion Criteria

* patient suffering from juvenile rheumatic disease
* patient suffering hemophilia
* patient on the waiting list for posterior stabilized TKA or hinge joint.
* patient who suffers from a lesion of the ligaments due to surgery
* patient who is legally not capable to make decisions
* patient who suffer from cancer
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Maarten MC de Waal Malefijt, MD

Role: STUDY_CHAIR

Radboud University Medical Center

Locations

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UMC Radboud

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

References

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Meijerink HJ, Verdonschot N, van Loon CJ, Hannink G, de Waalmalefijt MC. Similar TKA designs with differences in clinical outcome: a randomized, controlled trial of 77 knees with a mean follow-up of 6 years. Acta Orthop. 2011 Dec;82(6):685-91. doi: 10.3109/17453674.2011.636677. Epub 2011 Nov 9.

Reference Type DERIVED
PMID: 22066559 (View on PubMed)

Other Identifiers

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FBW STRATEC 96856

Identifier Type: -

Identifier Source: secondary_id

HJM25577

Identifier Type: -

Identifier Source: org_study_id